At-home self-collection device offers an effective and preferred method to engage high BMI women in cervical cancer screening: method comparison study

Introduction: Cervical cancer (CxCa) screening rates are lower among women with high BMI in the US, leading to increased prevalence and worse outcomes from cervical dysplasia and cancer in this group. The main barriers to participation in screening relate to the in-clinic speculum exam, which could be overcome with an at-home self-collect (SC) screening device optimized for differing body types. Methods: This prospective method comparison study recruited 609 screening-eligible participants aged 25 to 65 years, enrolled from November 20, 2023, to April 5, 2024. SC was performed by the participant in a simulated home environment, using a novel device optimized for differing body sizes. Eligible participants collected a vaginal sample with the SC device, followed immediately by a clinician-collection (CC) sample using a speculum and broom. The sample pairs were shipped to the lab, where the SC sample was eluted into PreservCyt and tested on an FDA-approved high-risk human papillomavirus (hrHPV) test approved for primary screening. Participants completed usability and preference surveys. Endpoints included the detection of hrHPV between SC and CC samples, as well as other study measures, such as clinical sensitivity for high-grade cervical dysplasia, usability, and preferences by BMI category. Five hundred ninety (590/599) participants had data available for this sub-analysis, based on body mass index (height and weight were recorded via self-report). Results and preferences of participants with a higher BMI (≥ 35) are highlighted herein. Results: BMI ranged from 16 to 66 for the entire study group, with 114/590 (19.3%) representing a BMI of 35 or greater, comprising the analysis group. The agreement for detection of hrHPV was equivalent across BMI categories. Over a third (36.8%) of participants in Class II (BMI: 35–40) and Class III (BMI > 40) categories had delayed or avoided their cervical cancer screening, and 91% reported that they would be more likely to stay up to date with routine screening if an at-home self-collect option were available. Preferences for self-collect among women in Class II + categories were higher for a self-collect option for screening, reporting that SC made them feel more in control of their experience. Discussion: In women with a BMI ≥ 35, cervical cancer screening by SC with this uniquely designed device demonstrated equivalent or superior HPV detection performance and was strongly preferred by participants. Offering this option could improve screening rates in women with BMI ≥ 35, a group that represents a significant portion of the US population who delay screening and help reduce disparities in cervical cancer incidence and outcomes.